The OCR Core Facility's mission is to support the highest quality program of clinical research at MSKCC through central management, standardized practice and oversight of clinical research and training. The overall aim of the OCR is to ensure that there are research standards, and clinical research policies and procedures to adhere to those standards. The OCR, in conjunction with the Protocol Review and Monitoring System, is a critical resource for the Center's Clinical Research Program, and interacts with the Basic Science, Bridge and Prevention, Control and Population Research Programs. The OCR is comprised of four divisions, each of which supports the overall mission of the Core Facility through distinct functions and responsibilities relating to the Center's clinical research activities: 1) The Protocol Development Office (PDO) provides Center staff with appropriate information, training, education and guidance on many facets of clinical research development, in adherence to institutional standards and federal regulatory requirements, from the time of protocol writing through trial completion. 2) The Office of Research Management develops, implements, and monitors research management standards, and ensures that good clinical practice (GCP) guidelines and federal regulations are followed throughout the Center; they are the central office that collaborates with all of the clinical departments, investigators and research staff, and provides the management oversight and maintenance to the Center's protocolpatient registry, which includes consent and patient eligibility verification. 3) The Data Management Resource provides technical expertise to investigators regarding their data and protocol management needs, and participates in the design, implementation and maintenance of the centralized clinical research database. 4) The Office of Quality Control and Quality Assurance ensures that Center staff adheres to the federal regulatory requirements of GCP and GMP, through the development, implementation, and monitoring of research policies, and the direct oversight of the Clinical Research Program and in-house product development.